Job Posting Title:
IRB Manager, Minimal Risk Research, Office of Research Support and Compliance
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Hiring Department:
Office of Research Support and Compliance
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Position Open To:
All Applicants
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Weekly Scheduled Hours:
40
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FLSA Status:
Exempt
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Earliest Start Date:
Immediately
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Position Duration:
Expected to Continue
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Location:
AUSTIN, TX
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Job Details:
General Notes
The Office of Research Support and Compliance (ORSC) at The University of Texas at Austin functions to ensure that all research conducted at the University is in compliance with applicable laws, regulations, and University policies. The ORSC educates and supports the University research community with regulatory guidance concerning human subjects research (Institutional Review Board), animal research (Institutional Animal Care and Use Committee), use of biohazardous agents and use of recombinant or synthetic nucleic acids (Institutional Biosafety Committee), financial conflict of interest in research (FCOI), and research integrity education.
UT Austin offers a competitive benefits package that includes:
Please visit our Human Resources (HR) website to learn more about the total benefits offered.
Purpose
The IRB Manager, Minimal Risk Research is a member of the Human Research Protection Program (HRPP), Institutional Review Board (IRB) leadership team, with shared responsibility for success of the IRB program in accomplishing strategic goals. The IRB Manager will facilitate ethical conduct of research with human subjects that is compliant with federal, state, and institutional requirements by providing daily operational oversight to the IRB Minimal Risk Research team. The IRB Manager plans, develops, and implements processes and materials to ensure quality and timely reviews of human research protocols.
Responsibilities
Conduct non-committee IRB reviews
Conduct in-depth reviews on assigned IRB submissions to ensure submissions are adequately prepared and meet all regulatory criteria for approval or exemption from federal regulations or “not human subjects research (NSHR)” criteria.
Identify regulatory issues requiring correction prior to approval and correspond in a clear and concise manner with investigators, coordinators, and/or other appropriate study personnel to resolve identified issues.
Work collaboratively with colleagues and researchers to ensure all reviews are completed accurately and in a timely manner.
Serves as an alternate voting member on the IRB committee and is designated to independently conduct expedited IRB reviews of research involving human subjects.
Interprets and successfully applies federal regulations, state law, accreditation standards, and institutional policy to research submissions at all stages of IRB review.
Identifies issues or concerns that must be addressed in order to approve the research.
Attends and participates in committee meetings, as needed.
Acts as Privacy Board member to assess applicability and provide determination regarding requests for HIPAA authorization waivers.
Works with other IRB Managers to coordinate activities as needed.
Directly Supervise IRB Analyst(s) and Sr. Analyst(s) on Assigned Team
Manages a team of IRB Analysts and oversees the activities that support non-committee review of IRB submissions.
Manages team workload, monitors team productivity and ensures appropriate turnaround time and sufficient level of review and appropriate determinations.
Works collaboratively with other IRB Managers to triage and assign submissions to IRB Analysts, making an initial determination regarding necessary level of review.
Evaluates staff performance to include assessing quality, productivity, and efficiency and provides ongoing feedback to staff and HRPP leadership, as appropriate.
Holds regularly scheduled staff meetings.
Hires, trains, supervises, and oversees assigned IRB staff in the daily operations of the minimal risk research review team in the IRB office.
Facilitates professional development of direct reports
Manage Non-Committee Review Program Operations and Supports the Human Research Protection Program
Provides backup to the IRB staff with regard to IRB submission review when needed and as submission volume requires.
Identifies and addresses workflow issues as they arise so that quality and efficiency are optimally maintained.
Works collaboratively with IRB leadership to develop, implement, and revise Standard Operating Procedures (SOPs) to enhance efficiency and effectiveness of non-committee operations including procedures for investigators and SOPs for administrative function of the IRB.
Ensures compliance with policies and procedures and informs IRB team members of changes in policy and procedure in a timely fashion.
Provides feedback and suggestions to the HRPP leadership regarding the operations and needs of minimal risk research review team.
Utilizes IRB metrics to provide insight into opportunities for quality and process improvement; prepares and submit regular reports related to IRB and HRPP activities to leadership.
Serves as a resource to IRB and HRPP leadership for consultation regarding day-to-day IRB operations of Minimal Risk Research Team.
Works with IRB and HRPP leadership to develop procedures, work instructions, tools, templates, applications, and guidance to support IRB staff and the research community with respect to the IRB submission, review, and approval process.
Together with other IRB and HRPP leadership, maintains relationships with departmental research leadership and ancillary review departments to assess their needs and facilitate ongoing communication to support the submission, review, approval, and conduct of research with human subjects.
Demonstrates clear, high-level knowledge, practice, and application of HHS regulations, FDA regulations and guidance, HIPAA Privacy Rule, and institutional policies related to human subject protection and clinical research to ensure compliance.
Maintains current knowledge of evolving guidance and regulations.
Attend meetings, conferences and seminars on work-related topics.
Volunteer for and performs other job-related duties as needed and/or assigned.
Provides Support to Research Community
Serves as subject matter expert in state and federal laws and regulations as they apply to human subjects research and provides quality customer service and regulatory support to all constituents.
Serves as front line researcher support representative at least 1 day/week (rotating responsibilities with other IRB Managers/Sr. Staff as designated by IRB leadership).
Acts as a role model for other professionals by communicating responsively, respectfully, and positively.
Reinforces clear expectations for customer service and consultancy.
Investigates and answers regulatory questions from research community, including phone calls, emails, and in-person requests.
Manages issue and complaint resolution related to IRB submission and non-committee review processes.
Collaborates with other IRB Managers to supervise customer service initiatives provided by IRB Analyst staff (e.g., IRB Chat, helpline, email).
Required Qualifications
Bachelor’s degree and at least 3 years’ relevant experience in research administration or applicable research experience.
At least 2 years of related experience in an IRB or HRPP environment at an academic institution or in a health care setting.
Previous experience managing a team or providing leadership to staff. Ability to develop and implement staff training program.
Excellent interpersonal and communication skills, including the ability to diplomatically interact with researchers at various levels (e.g., faculty, research coordinators, students) and within the IRB team.
Ability to set priorities, meet deadlines and manage multiple projects.
Demonstrated ability to work efficiently in a complex regulatory environment and manage multiple simultaneous projects with meticulous attention to detail is critical.
Must be able to multi-task in a customer service setting where there may be multiple demands on time.
Proven ability in presenting written and verbal information, ideas, and concepts in a clear, concise, and professional manner.
Comprehensive knowledge of federal, state, and local regulations, policies and best practices governing human subjects research including: HHS-OHRP regulations, FDA regulations and university policy regarding human subjects research.
Ability to function independently, including the ability to determine when decisions can be appropriately made and when they must be referred to higher levels for consideration.
Proven ability to take initiative and follow-through on projects.
Current CIP certification or ability to successfully obtain CIP certification within 6 months of hire.
Relevant education and experience may be substituted as appropriate.
Preferred Qualifications
Master’s degree in relevant field.
Certified IRB Professional (CIP).
Experience managing IRB or HRPP staff at an academic institution.
Salary Range
$80,000 + depending on qualifications
Working Conditions
Required Materials
Please mark "yes" on the application for required materials. Failure to attach all additional materials listed may affect candidates being considered for the position.
Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.
Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above.
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Employment Eligibility:
Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.
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Retirement Plan Eligibility:
The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.
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Background Checks:
A criminal history background check will be required for finalist(s) under consideration for this position.
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Equal Opportunity Employer:
The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.
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Pay Transparency:
The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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Employment Eligibility Verification:
If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.
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E-Verify:
The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university’s company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following:
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Compliance:
Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031.
The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.
